Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure

NCT06207383 · tracked via the Priya Life Science Germany tracker

Sponsor

University Hospital, Geneva

Phase

Not applicable

Started

2024-10-01

Last updated

2024-12-06

Condition(s) studied

Atrial Fibrillation, PersistentHeart Failure

Investigational drug(s) / intervention(s)

Conduction system pacingAtrioventricular nodal ablationAtrial fibrillation ablation

Conduction system pacing: Conduction system pacing (either His bundle pacing or left bundle branch area pacing)

Atrioventricular nodal ablation: Catheter ablation of the atrioventricular node

Atrial fibrillation ablation: Catheter ablation of atrial fibrillation with pulmonary vein isolation (using technique of operator's choice, with additional lesions if deemed necessary)

Study summary

The goal of this clinical trial is to evaluate two treatment strategies in patients with chronic atrial fibrillation and heart failure, who are eligible for atrial fibrillation ablation. Patients will be randomized to either atrial fibrillation ablation or to implantation of a pacemaker with conduction system pacing followed by atrioventricular node ablation. The effect of treatment allocation on total mortality, cardiovascular hospitalization and heart failure hospitalization will be compared.

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

Inclusion Criteria: (i) Persistent AF with symptomatic HF despite medical therapy, considered to be suitable for AF ablation, with at most one previous PVI procedure. (ii) At least one prior hospital admission, or emergency room / HF clinic visit for HF in the past 2 years, with NT-pro-BNP \> 1000 pg/ml or BNP \> 250 pg/ml measured at any timepoint during this interval. (iii) Previous or current rate or rhythm control drug therapy. (iv) Age \> 60 years Exclusion Criteria: (i) NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy. (ii) Life expectancy \< 2 years. (iii) Need for major surgical intervention. (iv) Myocardial infarction, stroke or PCI within the previous 3 months. (v) Previously implanted or planned implantation of CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable. (vi) Participation in another controlled trial. (vii) Inability to sign and informed consent form.

Primary outcome measure(s)

Superiority endpoint — 1-4 years
Incidence of mortality and cardiovascular hospitalization in each arm
Non-inferiority endpoint — 1-4 years
Incidence of mortality and heart failure hospitalization in each arm

Trial sites (18)

Facility	City	Region	Status
St Elisabeth sister's Hospital	Graz	Austria	Not Yet Recruiting
Antwerp University Hospital	Antwerp	Belgium	Not Yet Recruiting
Acibadem City Clinic Tokuda University Hospital	Sofia	Bulgaria	Not Yet Recruiting
University Hospital, Kralovske Vinohrady	Prague	Czechia	Not Yet Recruiting
Heart and Lung Center, University of Helsinki	Helsinki	Finland	Recruiting
Hôpital Charles Nicolle	Rouen	France	Not Yet Recruiting
Herzzentrum Leipzig	Leipzig	Germany	Not Yet Recruiting
Semmelweis University	Budapest	Hungary	Not Yet Recruiting
Bologna University Hospital	Bologna	Italy	Not Yet Recruiting
University Hospital Maastricht	Maastricht	Netherlands	Not Yet Recruiting
Jagiellonian University	Krakow	Poland	Not Yet Recruiting
Hospital Universitario La Paz	Madrid	Spain	Not Yet Recruiting
Hospital Universitario y Politecnico La Fe	Madrid	Spain	Not Yet Recruiting
University Hospital Geneva	Geneva	Canton of Geneva	Recruiting
University Hospital of Basel	Basel	Switzerland	Recruiting
Inselspital	Bern	Switzerland	Recruiting
University Hospital of Zurich	Zurich	Switzerland	Recruiting
National Heart and Lung Institute, Imperial College London	London	United Kingdom	Not Yet Recruiting

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Other trials for the same condition

A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients Recruiting

Effects of Negative Pressure Ventilation Onto Hemodynamics and Right Ventricular Funktion in Patients After Implantation of a Left Ventricular Assist Device. Recruiting

Voice Analysis to Detect Pulmonary Arterial Pressure Changes in Heart Failure Recruiting

The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R) Recruiting

Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06207383 on ClinicalTrials.gov ↗ ← All trials in Germany